Comparison of Myocardial Infarction Patients Who Were Prescribed a Novel Antiplatelet Agent or Clopidogrel

Sponsor
Chan Joon Kim (Other)
Overall Status
Recruiting
CT.gov ID
NCT05599152
Collaborator
Chong Kun Dang Pharmaceutical (Industry)
3,000
1
29.4
102.1

Study Details

Study Description

Brief Summary

Myocardial infarction is defined according to icd-10 using the data base of South korea National Health Insurance Corporation, where personal identification information has already been removed, and detailed results are derived for each drug category.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The purpose of this study is to compare the prognosis of patients with clopidogrel after early discontinuation of ticagrelor/prasugrel with patients who maintained aspirin and ticagrelor/prasugrel as standard therapy in patients with acute myocardial infarction who underwent percutaneous coronary intervention.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    3000 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Retrospective
    Official Title:
    A Study of Clinical Outcomes in Patients With Myocardial Infarction Who Maintained Novel Antiplatelet Agents for 1 Year and Patients Who Switched to Clopidogrel Early
    Actual Study Start Date :
    May 21, 2020
    Anticipated Primary Completion Date :
    Nov 1, 2022
    Anticipated Study Completion Date :
    Nov 1, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    ticagrelor/prasugrel Group

    Patients with acute myocardial infarction who underwent percutaneous coronary intervention and maintained aspirin and ticagrelor/prasugrel as standard therapy.

    clopidogrel Group

    In patients with acute myocardial infarction who underwent percutaneous coronary intervention, discontinued ticagrelor/prasugrel and switched to clopidogrel

    Outcome Measures

    Primary Outcome Measures

    1. Composite of all-cause death, recurrent myocardial infarction, stroke, (ischemic and hemorrhagic ) and bleeding within one year. [Percutaneous coronary intervention after 1 Year]

      compared patients who maintained ticagrelor/Prasugrel with those who switched from ticagrelor/prasugrel to clopidogrel. All cause death Myocardial infarction Stroke Bleeding Categorical data is indicated by number (%) and analyzed by X2 statistics. Continuous variables are expressed as mean standard deviation (±SD) , and in the case of skewed distribution, comparison is made by Mann-Whitney test or Student t test. To balance differences in baseline characteristics, stabilized inverse probability of treatment weighting (sIPTW) is used. For further analysis, consider propensity score matching (PSM) with nearest neighbor method and standardized mortality ratio weighting (SMRW) estimation. Propensity score uses a generalized additive logistic model and considers demographic data (age, gender, hypertension, diabetes mellitus, heart failure hemodialysis).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients who have a diagnosis code for acute myocardial infarction indicated in the National Health Insurance data and data for drugs that have used ticagrelor/prasugrel for 30-90 days when hospitalized for the relevant disease.

    • Patients who switched to clopidogrel after 30-90 days.

    • Patients with a diagnosis code for Venus myocardial infarction and a prescription code for percutaneous cardiovascular intervention in the National Health Insurance data.

    • Adults 18 years of age or older

    Exclusion Criteria:
    • A person who has data for requesting blood transfusion during the period of hospitalization in the National Health Insurance data

    • Those who have data for oral anticoagulants (warfarin, Coumadin, apixaban, edoxaban, dabigatran, rivaroxaban) in the National Health Insurance data

    • Those who have a diagnosis code for malignant tumor in the National Health Insurance data

    • Those who have end-stage renal failure code in the National Health Insurance data or those who have data for hemo/peritoneal dialysis

    • A person who has a request for blood transfusion during the period of using Ticagrelor/prasugrel

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Catholic University of Korea, Uijeongbu ST. Mary's Hospital Uijeongbu Korea, Republic of 11765

    Sponsors and Collaborators

    • Chan Joon Kim
    • Chong Kun Dang Pharmaceutical

    Investigators

    • Principal Investigator: Chan Joon Kim, The Catholic University of Korea, Uijeongbu ST. Mary's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Chan Joon Kim, professor, Uijeongbu St. Mary Hospital
    ClinicalTrials.gov Identifier:
    NCT05599152
    Other Study ID Numbers:
    • CKD-HIRA-Data-Review
    First Posted:
    Oct 31, 2022
    Last Update Posted:
    Oct 31, 2022
    Last Verified:
    Oct 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Chan Joon Kim, professor, Uijeongbu St. Mary Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 31, 2022